Influence of Graded Hypercapnia on Endurance Exercise Performance

Hypercapnia Clinical Trial

Official title:

Influence of Graded Hypercapnia on Endurance Exercise Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05116397
• Other study ID #: USARIEM
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: May 2022
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized, single-blind, placebo-controlled crossover trial is to determine the effects of graded hypercapnia (0, 2, and 4% inspired CO2) on endurance performance. Twelve healthy and fit young adults (men and women) will complete this study. Participants will perform experimental trials on 3 separate days (one each breathing 0%, 2%, and 4% inspired CO2-all with normal 21% oxygen). During each trial, they will perform 10 minutes of submaximal treadmill walking exercise and then complete a self-paced 2-mile treadmill run time-trial.

Description:

Participants will undergo baseline measurements of pulmonary function and maximal oxygen uptake (VO2max). They will then complete two familiarization trials, with 10 minutes of submaximal exercise (~40%VO2max) followed by a self-paced 2-mile treadmill time trial. Lastly, they will complete three experimental trials, repeating the same submaximal and time-trial exercise procedures while breathing the test gas (0%, 2%, or 4% CO2-all with normal 21% oxygen). During the experimental trials, arterialized capillary blood samples will be collected at rest breathing room air, at rest breathing the test gas, and during submaximal exercise at 40% VO2max breathing the test gas. The primary outcome is 2-mile treadmill time-trial performance. Secondary outcomes include ventilation, metabolic rate, heart rate, arterialized capillary pH/PCO2/HCO3, perceived exertion, dyspnea, leg discomfort, breathing descriptors, and headache ratings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female, age 18-45

• In good health as determined by medical screening

• Passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only) or performs aerobic exercise at least 2 times per week and able to complete two mile run in = 21 minutes (Civilian Volunteers)

• Willing to not participate in any exercise or drink alcoholic beverages for 24 hours before each study visit.

• Willing to not take part in any strenuous exercise in the 36 hours before each visit.

• Willing not to drink caffeine or eat food until after testing on familiarization and performance testing visits (visits 2-6).

• Willing to maintain a similar dietary pattern in the 2 days before each familiarization and performance visits.

• Have supervisor approval if permanent party military or a federal employee at U.S. Army Natick Soldier System Center

• Able to speak and read English fluently

Exclusion Criteria:

• Females who are pregnant or planning to become pregnant during the study

• Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by medical staff & PI)

• Musculoskeletal injuries that compromise ability to run on a treadmill

• Abnormal blood count, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)

• Smokers or tobacco/nicotine users (unless have quit > 1 month prior)

• Any history of asthma

• Current or recent respiratory tract or sinus infections (< 1 month prior)

• Allergy to skin adhesive

• Any history of migraine or recurrent headaches

• Any history of panic disorder

• Blood donation in the previous 8 weeks

• Positive Covid-19 test within the last month

Related Conditions & MeSH terms

• Hypercapnia

Intervention

Other:
• Inspired gas
Inspired gas content

Locations

Country	Name	City	State
United States	USARIEM	Natick	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 mile self-paced treadmill time trial performance	Time to complete self-paced 2 mile treadmill time trial (min:sec)	30 minutes
Secondary	Ventilation rate	Ventilation rate will be assessed using a pneumotachometer [L/min]	30 minutes
Secondary	Oxygen consumption	Oxygen consumption will be assessed using computerized indirect calorimetry [ml/kg/min]	30 minutes
Secondary	Heart rate	Heart rate will be assessed using telemetry [beats per min]	30 minutes
Secondary	Arterialized capillary pH	Arterialized capillary pH will be assessed using a blood gas analyzer [Unitless]	30 minutes
Secondary	Arterialized capillary pCO2	Arterialized capillary pCO2 will be assessed using a blood gas analyzer [mmHg]	30 minutes
Secondary	Arterialized capillary HCO3	Arterialized capillary HCO3 will be assessed using a blood gas analyzer [mEq/L]	30 minutes
Secondary	Rating of perceived exertion	Rating of perceived exertion will be assessed using Borg's 6-20 scale [AU]	30 minutes
Secondary	Dyspnea	Rating of perceived dyspnea will be assessed using Borg's 0-10 scale [AU]	30 minutes
Secondary	Leg discomfort	Rating of perceived leg discomfort will be assessed using Borg's 0-10 scale [AU]	30 minutes
Secondary	Headache	Headache will be assessed using a visual analog scale [AU]	30 minutes
Secondary	Breathing descriptors	Breathing descriptors will be assessed by having participants check statements that apply to their breathing (e.g., breathing out requires more effort) [unitless]	30 minutes